Cost-effectiveness of behavioral and pelvic floor muscle therapy combined with midurethral sling surgery vs surgery alone among women with mixed urinary incontinence: results of the Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence randomized trial.

BACKGROUND: Urinary incontinence is prevalent among women, and it has a substantial economic impact. Mixed urinary incontinence, with both stress and urgency urinary incontinence symptoms, has a greater adverse impact on quality of life and is more complex to treat than either stress or urgency urinary incontinence alone. Studies evaluating the cost-effectiveness of treating both the stress and urgency urinary incontinence components simultaneously are lacking. OBJECTIVE: Cost-effectiveness was assessed between perioperative behavioral and pelvic floor muscle therapies combined with midurethral sling surgery and midurethral sling surgery alone for the treatment of women with mixed urinary incontinence. The impact of baseline severe urgency urinary incontinence symptoms on cost-effectiveness was assessed. STUDY DESIGN: This prospective economic evaluation was performed concurrently with the Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence randomized trial that was conducted from October 2013 to April 2016. Participants included 480 women with moderate-to-severe stress and urgency urinary incontinence symptoms and at least 1 stress urinary incontinence episode and 1 urgency urinary incontinence episode on a 3-day bladder diary. The primary within-trial analysis was from the healthcare sector and societal perspectives, with a 1-year time horizon. Costs were in 2019 US dollars. Effectiveness was measured in quality-adjusted life-years and reductions in urinary incontinence episodes per day. Incremental cost-effectiveness ratios of combined treatment vs midurethral sling surgery alone were calculated, and cost-effectiveness acceptability curves were generated. Analysis was performed for the overall study population and subgroup of women with Urogenital Distress Inventory irritative scores of ≥50th percentile. RESULTS: The costs for combined treatment were higher than the cost for midurethral sling surgery alone from both the healthcare sector perspective ($5100 [95% confidence interval, $5000-$5190] vs $4470 [95% confidence interval, $4330-$4620]; P<.01) and the societal perspective ($9260 [95% confidence interval, $8590-$9940] vs $8090 [95% confidence interval, $7630-$8560]; P<.01). There was no difference between combined treatment and midurethral sling surgery alone in quality-adjusted life-years (0.87 [95% confidence interval, 0.86-0.89] vs 0.87 [95% confidence interval, 0.86-0.89]; P=.90) or mean reduction in urinary incontinence episodes per day (-4.76 [95% confidence interval, -4.51 to 5.00] vs -4.50 [95% confidence interval, -4.25 to 4.75]; P=.13). When evaluating the overall study population, from both the healthcare sector and societal perspectives, midurethral sling surgery alone was superior to combined treatment. The probability that combined treatment is cost-effective compared with midurethral sling surgery alone is ≤28% from the healthcare sector and ≤19% from the societal perspectives for a willingness-to-pay value of ≤$150,000 per quality-adjusted life-years. For women with baseline Urogenital Distress Inventory irritative scores of ≥50th percentile, combined treatment was cost-effective compared with midurethral sling surgery alone from both the healthcare sector and societal perspectives. The probability that combined treatment is cost-effective compared with midurethral sling surgery alone for this subgroup is ≥90% from both the healthcare sector and societal perspectives, at a willingness-to-pay value of ≥$150,000 per quality-adjusted life-years. CONCLUSION: Overall, perioperative behavioral and pelvic floor muscle therapies combined with midurethral sling surgery was not cost-effective compared with midurethral sling surgery alone for the treatment of women with mixed urinary incontinence. However, combined treatment was of good value compared with midurethral sling surgery alone for women with baseline severe urgency urinary incontinence symptoms.

The Design of a Prospective Trial to Evaluate the Role of Preoperative Frailty Assessment in Older Women Undergoing Surgery for the Treatment of Pelvic Organ Prolapse: The FASt Supplemental Trial.

OBJECTIVE: We present the rationale for and the design of a prospective trial to evaluate the role of preoperative frailty and mobility assessments in older women undergoing surgery for the treatment of pelvic organ prolapse (POP) as a planned prospective supplemental trial to the ASPIRe (Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design) trial. The Frailty ASPIRe Study (FASt) examines the impact of preoperative frailty and mobility on surgical outcomes in older women (≥65 years) participating in the ASPIRe trial. The primary objective of FASt is to determine the impact of preoperative age, multimorbidity, frailty, and decreased mobility on postoperative outcomes in older women (≥65 years old) undergoing surgery for POP. METHODS: The selection of the preoperative assessments, primary outcome measures, and participant inclusion is described. Frailty and mobility measurements will be collected at the preoperative visit and include the 6 Robinson frailty measurements and the Timed Up and Go mobility test. The main outcome measure in the FASt supplemental study will be moderate to severe postoperative adverse events according to the Clavien-Dindo Severity Classification. CONCLUSIONS: This trial will assess impact of preoperative age, multimorbidity, frailty, and decreased mobility on postoperative outcomes in older women (≥65 years old) undergoing surgical procedures for the correction of apical POP. Information from this trial may help both primary care providers and surgeons better advise/inform women on their individual risks of surgical complications and provide more comprehensive postoperative care to women at highest risk of complications.

A Novel, Structured Fellow Training Pathway for Robotic-Assisted Sacrocolpopexy.

INTRODUCTION: We developed a novel fellow education pathway for robotic-assisted sacrocolpopexy (RASC) and aimed to compare step-specific and total operative times for RASC performed by Female Pelvic Medicine and Reconstructive Surgery (FPMRS) attendings with those in which FPMRS fellows performed part or all of the RASC. We further aimed to compare complication and readmission rates by fellow involvement. METHODS: We tracked RASC at 1 institution between 2012 and 2018. We recorded times for total procedure, sacrocolpopexy, and 6 individual steps. Fellows were designated F1-F3 by training year. We used independent samples t-tests and analysis of variance for continuous variables and χ2 and Fisher's exact tests for categorical variables. RESULTS: Of 178 RASC procedures, 76 (42.7%) involved fellows. Concomitant procedures included hysterectomy (62.4%), midurethral sling (50%), and colporrhaphy/perineorrhaphy (51.7%). RASC without and with fellows had similar demographic, clinical, and procedural characteristics, except for midurethral sling rate (attending, 42.2% vs fellow, 60.5%; p = 0.02). RASC without and with fellows had similar times for total procedure (208.9 ± 61.0 vs 209.1 ± 48.6 minutes, p = 0.98), sacrocolpopexy (116.9 ± 39.9 vs 122.7 ± 29.2 minutes, p = 0.27), and all RASC steps except docking (attendings, 9.9 ± 8.6 vs fellows, 7.2 ± 7.0 minutes; p = 0.03). Complication rates and severity were similar without and with fellows. There were no readmissions. DISCUSSION/CONCLUSION: Our novel structured training program provides safe limitations for total and step-specific procedural times during fellowship education in RASC. Such training programs warrant further study to determine potential contribution to quality and safety in the teaching environment.

Laparoscopic Hysterectomy and Urinary Tract Injury: Experience in a Health Maintenance Organization.

STUDY OBJECTIVES: To evaluate the incidence, detection, characteristics, and management of urinary tract injury in a cohort undergoing laparoscopic hysterectomy, and to identify potential risk factors for urinary tract injury with laparoscopic hysterectomy. DESIGN: Retrospective analysis (Canadian Task Force classification II-2). SETTING: Kaiser Permanente San Diego Medical Center, 2001 to 2012. PATIENTS: Women who underwent attempted laparoscopic hysterectomy for benign indications. INTERVENTIONS: Total laparoscopic hysterectomy, laparoscopic-assisted vaginal hysterectomy, and laparoscopic supracervical hysterectomy. MEASUREMENTS AND MAIN RESULTS: Demographic and clinical characteristics, surgical techniques, and perioperative complications were abstracted from the medical record. Multivariable logistic regression analysis assessed independent risk factors for ureteral or bladder injury. RESULTS: A total of 3523 patients (mean age, 45.9 ± 8.0 years; median parity, 2; range, 0-10), with a median body mass index (BMI) of 29 kg/m(2) (range, 16-72 kg/m(2)), underwent laparoscopic hysterectomy; 20% had intraoperative cystoscopy. The incidence of urinary tract injury was 1.3% (46 of 3523); of the 46 patients with injuries, 19 (0.54%) had ureteral injuries, 25 (0.71%) had bladder injuries, and 2 (0.06%) had both types. Of the 21 ureteral injuries, 6 (29%) were diagnosed intraoperatively and 15 (71%) were diagnosed postoperatively, including 4 with normal intraoperative cystoscopy. Of the 27 bladder injuries, 23 (85%) were identified intraoperatively. In multivariable logistic analysis, a BMI of 26 to 30 kg/m(2) (compared with >30 kg/m(2)) was associated with an increased risk of ureteral injury, and a BMI ≤25 kg/m(2) (compared with >30 kg/m(2)) and the presence of endometriosis were associated with an increased risk of bladder injury. CONCLUSION: Urinary tract injury occurred in 1.3% of laparoscopic hysterectomies, with ureteral injuries almost as common as bladder injuries. Normal intraoperative cystoscopy findings did not exclude the presence of ureteral injury.

Trends in urodynamics study utilization in a Southern California managed care population.

OBJECTIVE: We examined trends in overall and preoperative urodynamics utilization among women with stress urinary incontinence (SUI) to determine if practice patterns changed following publication of a 2012 randomized trial questioning the value of preoperative urodynamics in patients with uncomplicated SUI. STUDY DESIGN: We collected electronic medical record data on the number of female patient visits to Kaiser Permanente Southern California urology and urogynecology clinics with stress or mixed incontinence, urodynamic studies (UDS) performed, surgeries performed for stress incontinence, and the demographic and clinical characteristics of these patients during 2 discrete time periods before and after a potentially practice-changing publication. We used χ(2) tests and t tests as appropriate. A multivariate logistic regression model was used to estimate the odds of urodynamics performed during January 2013 through June 2014 (study period 2) compared to urodynamics performed during July 2010 through December 2011 (study period 1) after adjustment for demographic and clinical characteristics. RESULTS: In all, 33,775 women were diagnosed as having SUI or mixed urinary incontinence during study period 1 and 37,238 women were diagnosed with these conditions during study period 2. Among these women 12.8% underwent UDS in study period 1 compared to 8.4% in study period 2 (P < .01). The rate of UDS per patient visit decreased 27.0% between the 2 time periods (P < .01). In women undergoing surgery for stress incontinence, urodynamics were performed 56.5% of the time in study period 1 and 46.5% of the time in study period 2. After controlling for demographic, pelvic organ prolapse, and other bladder diagnoses, the odds of urodynamics performed in study period 2 was 0.54 times the odds of urodynamics performed in study period 1 (95% confidence interval, 0.52-0.57). Among women with only the diagnosis of stress incontinence, 1.78% underwent urodynamics in study period 1 compared with 0.84% in study period 2 (P < .01). Preoperative urodynamics decreased from 39% in study period 1 to 20% in study period 2 (P < .01). CONCLUSION: Significantly fewer UDS are being performed overall and prior to stress incontinence surgery in this population. This change may be due to recent studies suggesting low utility of urodynamics in patients with uncomplicated, stress-dominant incontinence.

The Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment: ROSETTA trial.

We present the rationale for and design of a randomized, open-label, active-control trial comparing the effectiveness of 200 units of onabotulinum toxin A (Botox A®) versus sacral neuromodulation (InterStim®) therapy for refractory urgency urinary incontinence (UUI). The Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment (ROSETTA) trial compares changes in urgency urinary incontinence episodes over 6 months, as well as other lower urinary tract symptoms, adverse events and cost effectiveness in women receiving these two therapies. Eligible participants had previously attempted treatment with at least 2 medications and behavioral therapy. We discuss the importance of evaluating two very different interventions, the challenges related to recruitment, ethical considerations for two treatments with significantly different costs, follow-up assessments and cost effectiveness. The ROSETTA trial will provide information to healthcare providers regarding the technical attributes of these interventions as well as the efficacy and safety of these two interventions on other lower urinary tract and pelvic floor symptoms. Enrollment began in March, 2012 with anticipated end to recruitment in mid 2014.

An update on the current and future demand for care of pelvic floor disorders in the United States.

OBJECTIVE: In 2001, we predicted a 45% increase in the demand for care of women with pelvic floor disorders (PFDs) between 2000 and 2030. However, in 2010, we observed that in our clinic demand for care had increased substantially more than expected. Using updated data, we sought to provide more accurate projections of future demand for care of pelvic floor disorders in the United States. STUDY DESIGN: Demographic data on all new female patients between 30 and 89 years of age seen for pelvic floor disorders in our Urogynecology Clinic between 2009 and 2011 were analyzed. These data were combined with United States Census Bureau projections for 2010 and 2030 stratified by 10-year age blocks. RESULTS: In 2010, our clinic saw a 116% increase in new patients per year compared with 2000. There was an 85% increase in new patient visits per 1000 women per year compared with 2000. We estimate that 1,218,371 new patient visits took place in the United States in 2010 and predict 1,644,804 visits will occur in 2030. CONCLUSION: If the United States population increases 24% by 2030 as projected by the United States Census Bureau, we predict the demand for care for pelvic floor disorders will increase by 35% between 2010 and 2030. This new, more accurate projection for 2030 is based on improved baseline data from 2010 and is 72% higher than we predicted in 2000. Accurately quantifying this growing demand for care of pelvic floor disorders is important for public health planning and physician training.

Robotic-assisted and laparoscopic sacrocolpopexy: comparing operative times, costs and outcomes.

OBJECTIVES: : To compare operative times, hospital costs, and surgical outcomes for robotic-assisted laparoscopic sacrocolpopexy (RALSC) and laparoscopic sacrocolpopexy (LSC). METHODS: : A retrospective cohort study of 104 subjects who underwent RALSC (n = 43) or LSC (n = 61) for vaginal vault prolapse was performed. The primary outcomes were operative time and hospital costs. The secondary outcomes included blood loss, complications, and objective cure rates. χ and t tests were used. RESULTS: : The mean operative time was longer in RALSC than in LSC (281 ± 58 vs 206 ± 42 minutes; P < 0.001) with setup time accounting for only 9 minutes of this difference. Direct costs (expressed in cost units) for hospital stay were similar (437 ± 88 vs 450 ± 119 units; P = 0.738) while surgical costs remained higher for RALSC (2724 ± 413 vs 2295 ± 342 units; P < 0.01). Blood loss and complications were similar, and objective cure was not significantly different for RALSC vs LSC (90% vs 80%, P = 0.19). CONCLUSIONS: : Robotic-assisted laparoscopic sacrocolpopexy achieves similar perioperative outcomes compared to LSC with increased surgical time resulting in increased costs.

Operations and pelvic muscle training in the management of apical support loss (OPTIMAL) trial: design and methods.

The primary aims of this trial are: 1) to compare surgical outcomes following sacrospinous ligament fixation to uterosacral vaginal vault suspension in women undergoing vaginal surgery for apical or uterine pelvic organ prolapse and stress urinary incontinence and 2) to examine the effects of a structured perioperative program consisting of behavioral techniques and pelvic floor muscle training compared to usual care. This trial is performed through the Pelvic Floor Disorders Network (PFDN), which is funded by National Institute of Child Health and Human Development. Subjects will be enrolled from hospitals associated with seven PFDN clinical centers across the United States. A centralized biostatistical coordinating center will oversee data collection and analysis. Two approaches will be investigated simultaneously using a 2x2 randomized factorial design: a surgical intervention (sacrospinous ligament fixation versus uterosacral vaginal vault suspension) and a perioperative behavioral intervention (behavioral and pelvic floor muscle training versus usual care). Surgeons have standardized essential components of each surgical procedure and have met specific standards of expertise. Providers of the behavioral intervention have undergone standardized training. Anatomic, functional, and health-related quality of life outcomes will be assessed using validated measures by researchers blinded to all randomization assignments. Cost-effectiveness analysis will be performed using prospectively collected data on health care costs and resource utilization. The primary surgical endpoint is a composite outcome defined by anatomic recurrence, recurrence of bothersome vaginal prolapse symptoms and/or retreatment and will be assessed 2 years after the index surgery. Endpoints for the behavioral intervention include both short-term (6-month) improvement in urinary symptoms and long-term (2-year) improvement in anatomic outcomes and prolapse symptoms. This article describes the rationale and design of this randomized trial, focusing on several key design features of potential interest to researchers in the field of female pelvic floor disorders and others conducting randomized surgical trials.

Sacral neuromodulation: cost considerations and clinical benefits.

OBJECTIVES: To demonstrate the efficacy of sacral neuromodulation and compare voiding-related health care utilization costs before and after receiving an implant. METHODS: A retrospective review of patients receiving InterStim therapy (Medtronic Neurological, Minneapolis, Minn) was completed. Health care utilization was determined for the year before and the year after implantation, and included hospital and clinic visits, diagnostic and therapeutic procedures, and prescriptions. Utilization costs were derived from Medicare CPT coding and reimbursement data. Drug costs were derived from the actual pharmacy costs. Efficacy was assessed subjectively by patient-reported questionnaire and objectively by voiding diary, pad usage, and number of catheterizations. RESULTS: Sixty-five patients received InterStim therapy. Outpatient visits for urinary symptoms decreased in the 12 months after implantation with a mean decrease of 2.2 visits (P <0.0001). This resulted in a 73% reduction in average yearly office visit expenses from $994 to $265 per patient. After implant, diagnostic and therapeutic procedures performed decreased by 0.97 (P <0.0001). This translated into a decrease in the cost of therapeutic and diagnostic procedures from $733 to $59 per patient (P <0.0001). Drug costs were significantly decreased (P <0.02) from $693 to $483 per patient. These cost savings represent a 92% reduction in outpatient doctor visits and diagnostic and procedure costs along with and a 30% reduction in drug expenditures. CONCLUSION: After InterStim therapy, voiding-related health care costs are reduced. InterStim therapy is an effective treatment option with high patient satisfaction for medically refractory voiding dysfunction.